MindMaze SA

Address:Chemin de Roseneck 5,Lausanne Vaud,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Interactive Rehabilitation Exercise Device, Prescription Use (QKC) (2) Exerciser, Non-Measuring (ION) (1)

Premarket Exempt

No Yes

Clear

MindMotion PRO - 03760272650002 Catalog Number :

Device Description : MindMotionPRO is a 3D imaging and display system that interactively displays and MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.

Device Class : 2

Duns Number: 486449510

Premarket Exempt : No

Product Code : QKC

Prescription Use : Yes

Device Count : 1

MindMotion™ GO - 03760272650019 Catalog Number :

Device Description : MindMotion™ GO is a medical device software used in combination with the Microso MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.

Device Class : 2

Duns Number: 486449510

Premarket Exempt : No

Product Code : QKC

Prescription Use : Yes

Device Count : 1

MindPod Dolphin - 03760272650026 Catalog Number :

Device Description : MindPod Dolphin is immersive serious gaming software for adult patients and heal MindPod Dolphin is immersive serious gaming software for adult patients and healthy participants. MindPod Dolphin motivates patients and participants to make high-intensity and high-dose non-task oriented upper-body exploratory movements in a challenging and beautiful environment. This targets motor and cognitive rehabilitation and provides a form of exercise. The experience can be provided under either continuous or intermittent supervision by a caregiver.

Device Class : 1

Duns Number: 486449510

Premarket Exempt : Yes

Product Code : ION

Prescription Use : Yes

Device Count : 1

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